Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence

An observational study of Constipation and Fecal Incontinence, run by Cantonal Hospital of St. Gallen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation, Fecal Incontinence
What is being tested?: sacral nerve modulation
Type of treatment: Medical device
How many people: 101 participants
Where: No sites listed yet
Study dates: Apr 2016to Sep 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015

Who may be able to join

Patients who had received an SNM treatment in the last 10 years

Who cannot join

pudendal nerve stimulation
refusal to allow use of clinical data for retrospective data analysis

About this study

Conditions: Constipation, Fecal Incontinence
Being tested: sacral nerve modulation
Keywords: sacral nerve modulation, quality of life, stimulator maintenance, SNM
Medical subject headings: Constipation, Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sacral nerve modulationDevice
electric stimulation of the sacral nerve using an implanted electrode and stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Considering the Treatment a Success After 5 Years
Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints
Measured: 5 years

Secondary outcomes (6)

Percentage of Patients Considering the Treatment a Success After 1 Years
Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints
Measured: 1 year
Percentage of Patients Considering the Treatment a Success After 3 Years
Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints
Measured: 3 year
Number of Patients at Risk After 1 Year
patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/).
Measured: 1 year
Number of Patients at Risk After 3 Years
patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/).
Measured: 3 year
Number of Patients at Risk After 5 Years
patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/).
Measured: 5 year
Rate of Permanent Stimulator Implantations
Rate of patients who finished the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence)
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Sep 2016

First posted19 Jul 2016 (estimated)
Study startApr 2016
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02836717
Sponsor's protocol ID: SGChir201601
Status last verified: Nov 2022
First submitted: 22 Jun 2016
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Widmann B, Galata C, Warschkow R, Beutner U, Ogredici O, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Motil. 2019 Jan 31;25(1):159-170. doi: 10.5056/jnm17106.
PubMed 30646487

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
ClinicalTrials.gov ID: NCT02836717
Acronym / sponsor ID: SGChir201601
Conditions: Constipation, Fecal Incontinence
Keywords: sacral nerve modulation, quality of life, stimulator maintenance, SNM
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Cantonal Hospital of St. GallenUniversity, hospital or other
Study start: Apr 2016 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 19 Jul 2016 (estimated)
Results: Posted 18 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015

Key inclusion criteria (1 listed)

Patients who had received an SNM treatment in the last 10 years

Key exclusion criteria (2 listed)

pudendal nerve stimulation
refusal to allow use of clinical data for retrospective data analysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sacral nerve modulationelectric stimulation of the sacral nerve using an implanted electrode and stimulator	Device	–

Primary outcome

Percentage of Patients Considering the Treatment a Success After 5 Years
Time frame: 5 years
Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints

6 secondary outcomes

Percentage of Patients Considering the Treatment a Success After 1 Years
Time frame: 1 year
Percentage of Patients Considering the Treatment a Success After 3 Years
Time frame: 3 year
Number of Patients at Risk After 1 Year
Time frame: 1 year
Number of Patients at Risk After 3 Years
Time frame: 3 year
Number of Patients at Risk After 5 Years
Time frame: 5 year
Rate of Permanent Stimulator Implantations
Time frame: 1 month

Results and safety

Results posted to the registry on 18 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FI Group	73	59
Con Group	16	8
FI+Con Group	12	12

Primary outcome: Percentage of Patients Considering the Treatment a Success After 5 Years

Time frame: 5 years. Number (95% Confidence Interval). Unit: percentage of success

Measure	All Patients n = 79	FI Group n = 59	Con Group n = 8	FI+Con Group n = 12
Value	81.7 (72.6 to 91.9)	87.3 (78.1 to 97.6)	31.2 (10.2 to 95.5)	91.7 (77.3 to 100)

Population analysed: Rate of successfully treated patients based on time-to-event ("Kaplan-Meier") statistic

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FI Group	28 of 59 (47.5%)	11 of 59 (18.6%)	1 of 59
Con Group	6 of 8 (75%)	1 of 8 (12.5%)	0 of 8
FI+Con Group	4 of 12 (33.3%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Observed death was unrelated to study treatment or study participation

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30646487Widmann B, Galata C, Warschkow R, Beutner U, Ogredici O, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Motil. 2019 Jan 31;25(1):159-170. doi: 10.5056/jnm17106.
Individual participant dataSharing planned: No

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lukas Marti, MD principal investigator

Cantonal Hospital of St. Gallen

Questions about this trial

What is this clinical trial studying?

An observational study of Constipation and Fecal Incontinence, run by Cantonal Hospital of St. Gallen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Considering the Treatment a Success After 5 Years (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02836717, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.